Tivicay
- Product NDC
- 49702-228
- Requested package NDC
- 49702-228-13
- 11-digit product format
- 497020228
- Labeler code
- 49702
- Product ID
- 49702-228_a9175b83-2200-4bd2-9ee3-52095b5d2657
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dolutegravir sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ViiV Healthcare Company
- Application
- NDA204790
- Marketing category
- NDA
- Marketing start
- 2013-08-13
- Substance
- DOLUTEGRAVIR SODIUM
- Active strength
- 50 mg/1
- Pharmacologic classes
- HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204790-001 | TIVICAY | DOLUTEGRAVIR SODIUM | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | |
| N204790-002 | TIVICAY | DOLUTEGRAVIR SODIUM | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | |
| N204790-003 | TIVICAY | DOLUTEGRAVIR SODIUM | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N204790-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2013-08-27 | |
| N204790-001 | 8129385*PED | 2028-04-05 | Pediatric extension | ||
| N204790-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-03-10 | |
| N204790-001 | 9242986*PED | 2030-06-08 | Pediatric extension | ||
| N204790-002 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | |
| N204790-002 | 8129385*PED | 2028-04-05 | Pediatric extension | ||
| N204790-002 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | |
| N204790-002 | 9242986*PED | 2030-06-08 | Pediatric extension | ||
| N204790-003 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | |
| N204790-003 | 8129385*PED | 2028-04-05 | Pediatric extension | ||
| N204790-003 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | |
| N204790-003 | 9242986*PED | 2030-06-08 | Pediatric extension |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-002 | TIVICAY | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-003 | TIVICAY | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-002 | TIVICAY | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-003 | TIVICAY | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-002 | TIVICAY | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-003 | TIVICAY | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-002 | TIVICAY | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-003 | TIVICAY | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204790-002 | TIVICAY | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204790-003 | TIVICAY | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204790-002 | TIVICAY | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204790-003 | TIVICAY | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2016-06-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204790-002 | TIVICAY | EQ 10MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204790-003 | TIVICAY | EQ 25MG BASE | TABLET / ORAL | RLD | 2016-06-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204790-001 | TIVICAY | EQ 50MG BASE | TABLET / ORAL | RLD, RS | 2013-08-12 | 8072bd15b7f6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N204790-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2013-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-001 | 8129385*PED | 2028-04-05 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204790-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-03-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-001 | 9242986*PED | 2030-06-08 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204790-002 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-002 | 8129385*PED | 2028-04-05 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204790-002 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-002 | 9242986*PED | 2030-06-08 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204790-003 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-003 | 8129385*PED | 2028-04-05 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204790-003 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204790-003 | 9242986*PED | 2030-06-08 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2013-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-001 | 8129385*PED | 2028-04-05 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-03-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-001 | 9242986*PED | 2030-06-08 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-002 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-002 | 8129385*PED | 2028-04-05 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-002 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-002 | 9242986*PED | 2030-06-08 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-003 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-003 | 8129385*PED | 2028-04-05 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-003 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204790-003 | 9242986*PED | 2030-06-08 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204790-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2013-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-001 | 8129385*PED | 2028-04-05 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204790-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-03-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-001 | 9242986*PED | 2030-06-08 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204790-002 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-002 | 8129385*PED | 2028-04-05 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204790-002 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-002 | 9242986*PED | 2030-06-08 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204790-003 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2016-06-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-003 | 8129385*PED | 2028-04-05 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204790-003 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-06-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204790-003 | 9242986*PED | 2030-06-08 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-001 | 8129385 | 2027-10-05 | Drug substance, Drug product | 2013-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-001 | 8129385*PED | 2028-04-05 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-001 | 9242986 | 2029-12-08 | Drug substance, Drug product | 2016-03-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204790-001 | 9242986*PED | 2030-06-08 | Pediatric extension | fd3edfee7708… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N204790-001 | I-758 | 2020-11-21 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N204790-002 | I-758 | 2020-11-21 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N204790-003 | I-758 | 2020-11-21 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N204790-001 | I-758 | 2020-11-21 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N204790-002 | I-758 | 2020-11-21 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N204790-003 | I-758 | 2020-11-21 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N204790-001 | I-758 | 2020-11-21 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N204790-002 | I-758 | 2020-11-21 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N204790-003 | I-758 | 2020-11-21 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N204790-001 | I-758 | 2020-11-21 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N204790-002 | I-758 | 2020-11-21 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N204790-003 | I-758 | 2020-11-21 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N204790-001 | I-758 | 2020-11-21 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N204790-002 | I-758 | 2020-11-21 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N204790-003 | I-758 | 2020-11-21 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N204790-001 | I-758 | 2020-11-21 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N204790-002 | I-758 | 2020-11-21 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N204790-003 | I-758 | 2020-11-21 | ea99ee380514… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tivicay
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOLUTEGRAVIR SODIUM | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1Q1V9V5WYQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1433873 | Internal RxNorm lookup |
| 1433879 | Internal RxNorm lookup |
| 1796077 | Internal RxNorm lookup |
| 1796079 | Internal RxNorm lookup |
| 1796081 | Internal RxNorm lookup |
| 1796083 | Internal RxNorm lookup |
| 2374562 | Internal RxNorm lookup |
| 2374566 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 63df5af3-b8ac-4e76-9830-2dbb340af922 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3832141c-c294-474a-9473-1052c891450e | Product name | 2 | 20230105 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 3644e9cf-6f4d-4b63-b875-6a4b5187c47e | Product name | 1 | 20190703 |
| 44633898-5724-4273-abcc-3541a1107946 | Product name | 1 | 20180124 |
| 7d3f81af-5024-0cff-2664-d433b7688444 | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49702-228-13 | Tivicay | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 31 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49702-228-13 | EA - Each | 49702-228 | a0c068b2-5b99-451c-82ca-f1fc15dcc6b6 | 1 | 2013-09-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49702-228 | TIVICAY PD (DOLUTEGRAVIR SODIUM) TABLET, FOR SUSPENSION TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] | 29 | Current NDC, Legacy NDC, 1 package rows | 20240907_63df5af3-b8ac-4e76-9830-2dbb340af922.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tivicay | DOLUTEGRAVIR SODIUM | ST. MARY'S MEDICAL PARK PHARMACY | 485bc9db-8665-9f5a-e063-6394a90a7921 | 2026-05-22 | Warnings, Adverse reactions | 204790 NDA204790 |
| Tivicay | DOLUTEGRAVIR SODIUM | ViiV Healthcare Company | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 2025-10-29 | Warnings, Adverse reactions | 204790 NDA204790 49702-228-13 49702-228 49702022813 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1796077 | dolutegravir 10 MG Oral Tablet | PSN | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1796081 | dolutegravir 25 MG Oral Tablet | PSN | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 2374562 | dolutegravir 5 MG Tablet for Oral Suspension | PSN | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1433873 | dolutegravir 50 MG Oral Tablet | PSN | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1796079 | Tivicay 10 MG Oral Tablet | PSN | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1796083 | Tivicay 25 MG Oral Tablet | PSN | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1433879 | Tivicay 50 MG Oral Tablet | PSN | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 2374566 | Tivicay PD 5 MG Tablet for Oral Suspension | PSN | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1796079 | dolutegravir 10 MG Oral Tablet [Tivicay] | SBD | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1796083 | dolutegravir 25 MG Oral Tablet [Tivicay] | SBD | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 2374566 | dolutegravir 5 MG Tablet for Oral Suspension [Tivicay] | SBD | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1433879 | dolutegravir 50 MG Oral Tablet [Tivicay] | SBD | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1796077 | dolutegravir 10 MG Oral Tablet | SCD | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1796081 | dolutegravir 25 MG Oral Tablet | SCD | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 2374562 | dolutegravir 5 MG Tablet for Oral Suspension | SCD | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1433873 | dolutegravir 50 MG Oral Tablet | SCD | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1796077 | dolutegravir 10 MG (as dolutegravir sodium) Oral Tablet | SY | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1796081 | dolutegravir 25 MG (as dolutegravir sodium) Oral Tablet | SY | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 2374562 | dolutegravir 5 MG (as dolutegravir sodium) Tablet for Oral Suspension | SY | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1433873 | dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral Tablet | SY | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1796079 | Tivicay 10 MG (as dolutegravir sodium) Oral Tablet | SY | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1796083 | Tivicay 25 MG (as dolutegravir sodium) Oral Tablet | SY | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1433879 | Tivicay 50 MG (as dolutegravir sodium) Oral Tablet | SY | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1433879 | Tivicay 50 MG Oral Tablet | SY | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 2374566 | Tivicay PD 5 MG (as dolutegravir sodium) Tablet for Oral Suspension | SY | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 2374566 | Tivicay PD 5 MG Tablet for Oral Suspension | SY | 63df5af3-b8ac-4e76-9830-2dbb340af922 | 31 |
| 1433873 | dolutegravir 50 MG Oral Tablet | PSN | b00132b8-58b1-7533-e053-2995a90a0cf1 | 5 |
| 1433879 | Tivicay 50 MG Oral Tablet | PSN | b00132b8-58b1-7533-e053-2995a90a0cf1 | 5 |
| 1433879 | dolutegravir 50 MG Oral Tablet [Tivicay] | SBD | b00132b8-58b1-7533-e053-2995a90a0cf1 | 5 |
| 1433873 | dolutegravir 50 MG Oral Tablet | SCD | b00132b8-58b1-7533-e053-2995a90a0cf1 | 5 |
| 1433873 | dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral Tablet | SY | b00132b8-58b1-7533-e053-2995a90a0cf1 | 5 |
| 1433879 | Tivicay 50 MG (as dolutegravir sodium) Oral Tablet | SY | b00132b8-58b1-7533-e053-2995a90a0cf1 | 5 |
| 1433879 | Tivicay 50 MG Oral Tablet | SY | b00132b8-58b1-7533-e053-2995a90a0cf1 | 5 |
| 1433873 | dolutegravir 50 MG Oral Tablet | PSN | 485bc9db-8665-9f5a-e063-6394a90a7921 | 2 |
| 1433873 | dolutegravir 50 MG Oral Tablet | PSN | 44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec | 2 |
| 1433879 | Tivicay 50 MG Oral Tablet | PSN | 485bc9db-8665-9f5a-e063-6394a90a7921 | 2 |
| 1433879 | Tivicay 50 MG Oral Tablet | PSN | 44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec | 2 |
| 1433879 | dolutegravir 50 MG Oral Tablet [Tivicay] | SBD | 485bc9db-8665-9f5a-e063-6394a90a7921 | 2 |
| 1433879 | dolutegravir 50 MG Oral Tablet [Tivicay] | SBD | 44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec | 2 |
| 1433873 | dolutegravir 50 MG Oral Tablet | SCD | 485bc9db-8665-9f5a-e063-6394a90a7921 | 2 |
| 1433873 | dolutegravir 50 MG Oral Tablet | SCD | 44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec | 2 |
| 1433873 | dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral Tablet | SY | 485bc9db-8665-9f5a-e063-6394a90a7921 | 2 |
| 1433873 | dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral Tablet | SY | 44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec | 2 |
| 1433879 | Tivicay 50 MG (as dolutegravir sodium) Oral Tablet | SY | 485bc9db-8665-9f5a-e063-6394a90a7921 | 2 |
| 1433879 | Tivicay 50 MG (as dolutegravir sodium) Oral Tablet | SY | 44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec | 2 |
| 1433879 | Tivicay 50 MG Oral Tablet | SY | 485bc9db-8665-9f5a-e063-6394a90a7921 | 2 |
| 1433879 | Tivicay 50 MG Oral Tablet | SY | 44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec | 2 |
| 1433873 | dolutegravir 50 MG Oral Tablet | PSN | 807b0cd2-093c-4353-a4a5-2e1f264616ba | 1 |
| 1433879 | Tivicay 50 MG Oral Tablet | PSN | 807b0cd2-093c-4353-a4a5-2e1f264616ba | 1 |
| 1433879 | dolutegravir 50 MG Oral Tablet [Tivicay] | SBD | 807b0cd2-093c-4353-a4a5-2e1f264616ba | 1 |
| 1433873 | dolutegravir 50 MG Oral Tablet | SCD | 807b0cd2-093c-4353-a4a5-2e1f264616ba | 1 |
| 1433873 | dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral Tablet | SY | 807b0cd2-093c-4353-a4a5-2e1f264616ba | 1 |
| 1433879 | Tivicay 50 MG (as dolutegravir sodium) Oral Tablet | SY | 807b0cd2-093c-4353-a4a5-2e1f264616ba | 1 |
| 1433879 | Tivicay 50 MG Oral Tablet | SY | 807b0cd2-093c-4353-a4a5-2e1f264616ba | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49702-228-13 | 49702022813 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-228-13) | 2013-08-13 | 0000-00-00 | No | No | Current |